Regulatory News In Brief

The Physician Payments Sunshine Act finally cleared CMS review Nov. 27 and was sent to the Office of Management and Budget for final review. The rule, passed as part of the Affordable Care Act, governs the transparency of industry gifts to health care professionals. CMS has been widely criticized for its delays in clearing the rule. (See Also see "CMS Catches Criticism For Continued Delays With Sunshine Rule" - Medtech Insight, 17 September, 2012..) On Nov. 18, Medtronic and the Pew Charitable Trusts sent a joint letter to CMS Acting Administrator Marilyn Tavenner urging that final regulations be released no later than this December so that manufacturers can begin implementing procedures for collecting payment information. The law is supposed to go into effect Jan. 1, 2013, with manufacturers reporting gift data by March 31, but delays in issuing final regulations have made these deadlines unfeasible, the groups wrote.

FDA Commissioner Margaret Hamburg signed two cooperative agreements with international regulatory agencies at the 7th Summit of Heads of Medicines Regulatory Agencies in Manaus, Brazil, held Nov. 26-29, according to...